Fuzeon

"The combinations of anti-HIV drugs recommended for pregnant women do not appear in general to increase their children's risk for language delay, according to a study from a National Institutes of Health research network.

For Patients

Fuzeon (enfuvirtide) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS), and is usually given after other medications have been tried without successful treatment of HIV. It is not a cure for HIV or AIDS. It is a type of antiviral medication called a fusion inhibitor. Common side effects include pain, redness, itching, bruising, hardened skin, or bumps at the injection site. These types of reactions are common and may last up to 7 days. Runny nose may also occur.

The recommended dose of Fuzeon is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Fuzeon may interact with blood thinners. Tell your doctor all medications and supplements you use. Fuzeon should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Fuzeon (enfuvirtide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; fever with vomiting; blood in your urine; difficulty breathing; fainting; swelling of your feet, face, lips, tongue, or throat.

Stop using enfuvirtide and call your doctor at once if you have any of these serious side effects:

SIDE EFFECTS: Pain, redness, itching, bruising, hardened skin, or bumps at the injection site may occur. These types of reactions are common and may last up to 7 days. Runny nose may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor right away if you have any serious side effects, including: anxiety, numbness/tingling/shooting nerve pain near injection site, signs of injection site infection (such as oozing, warmth, persistent pain and redness), abdominal pain, loss of appetite.

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing, fever, chills, nausea/vomiting.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

The overall safety profile of FUZEON is based on 2131
subjects who received at least 1 dose of FUZEON during various clinical trials.
This includes 2051 adults, 658 of whom received the recommended dose for
greater than 48 weeks, and 63 pediatric subjects.

Assessment of treatment-emergent adverse events is based
on the pooled data from the two randomized, controlled, open-label, multicenter
trials in treatment-experienced subjects, T20-301 (TORO 1) and T20-302 (TORO
2).

Local Injection Site Reactions

Local injection site reactions were the most frequent
adverse events associated with the use of FUZEON. In T20-301 and T20-302, 98%
of subjects had at least one local injection site reaction (ISR). A total of 7%
of subjects discontinued treatment with FUZEON because of ISRs (4%) or
difficulties with injecting FUZEON (3%) such as injection fatigue and
inconvenience. Eighty-five percent of subjects experienced their first ISR
during the initial week of treatment; ISRs continued to occur throughout
treatment with FUZEON. For most subjects the severity of signs and symptoms
associated with ISRs did not change during the 48 weeks of treatment. The
majority of ISRs were associated with erythema, induration, the presence of
nodules or cysts, and mild to moderate pain at the injection site (Table 2). In
addition, the average duration of individual ISRs was between three and seven days
in 41% of subjects and more than seven days in 24% of subjects. Also, the
numbers of ISRs per subject at any one time was between six to 14 ISRs in 26%
of subjects and more than 14 ISRs in 1.3% of subjects. Infection at the
injection site (including abscess and cellulitis) was reported in 1.7% of adult
subjects.

Table 2 : Summary of Individual Signs/Symptoms
Characterizing Local Injection Site Reactions to Enfuvirtide in Studies T20-301
and T20-302 Combined (% of Subjects) Through 48 Weeks

Other Adverse Events

In T20-301 and T20-302, after
study week 8, subjects on background alone who met protocol defined criteria
for virological failure were permitted to revise their background regimens and
add FUZEON. Exposure on FUZEON+background was 557 patient-years, and to
background alone 162 patient-years. Due to this difference in exposure, safety
results are expressed as the number of patients with an adverse event per 100
patient-years of exposure. For FUZEON+background, adverse events are also
displayed by percent of subjects.

The events most frequently
reported in subjects receiving FUZEON+background regimen, excluding ISRs, were
diarrhea (38 per 100 patient-years or 31.7%), nausea (27 per 100 patient-years
or 22.8%), and fatigue (24 per 100 patient-years or 20.2%). These events were
also commonly observed in subjects that received background regimen alone:
diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years), and
fatigue (38 per 100 patient-years).

Treatment-emergent adverse
events, regardless of causality and excluding ISRs, from Phase 3 studies are
summarized for adult subjects, in Table 3. Any Grade 2 or above events
occurring at ≥ 2 percent of subjects and at a higher rate in subjects
treated with FUZEON are summarized in Table 3; events that occurred at a higher
rate in the control arms are not displayed.

Rates of adverse events for
subjects who switched to FUZEON after virological failure were similar.

Laboratory Abnormalities

Table 4 shows the
treatment-emergent laboratory abnormalities that occurred in at least 2 subjects
per 100 patient-years and more frequently in those receiving FUZEON+background
regimen than background regimen alone from T20-301 and T20-302.

Adverse Events in Pediatric
Patients

FUZEON has been studied in 63
pediatric subjects 5 through 16 years of age with duration of FUZEON exposure
ranging from 1 dose to 134 weeks. Adverse experiences seen during clinical
trials were similar to those observed in adult subjects, although infections at
site of injection (cellulitis or abscess) were more frequent in adolescents
than in adults, with 4 events occurring in 3 of 28 (11%) subjects.